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§5220. Ethylene Oxide.

(a) Scope and Application.

(1) This section applies to all occupational exposures to ethylene oxide (EtO) except as provided in subsection (a)(2).

(2) This section does not apply to the processing, use, or handling of products made from or containing EtO where objective data demonstrate that the product is not capable of releasing airborne EtO in concentrations at or above the action level under conditions of processing, use, or handling that would reasonably be expected to cause the greatest possible release.

(3) Where a product is exempted pursuant to subsection (a)(2), the employer shall maintain a record of the objective data supporting that exemption and the basis for the employer's reliance on the data, as provided in subsection (k)(1).

(4) Sections 5221 and 5222 also apply where EtO is used in walk-in chambers for fumigation or sterilization purposes.

(5) Every employer using EtO shall report such use(s) to the Chief in accordance with subsection (m) except to the extent that the use of EtO is exempt under the provisions of subsection (a)(2).

(b) Definitions: For the purpose of this section, the following definitions shall apply:

“Action Level.” Employee exposure to airborne EtO at an 8-hour time-weighted average concentration of 0.5 part EtO per million parts of air (0.5 ppm).

“Authorized Person.” Any person specifically authorized by the employer whose duties require the person to enter a regulated area, or any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring and measuring procedures under subsection (3).

“Chief.” The chief administrative officer of the Division of Occupational Safety and Health, P.O. Box 420603, San Francisco, CA 94142.

“Director.” The Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

“Emergency.” Any occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment that is likely to or does result in an unexpected significant release of EtO.

“Employee Exposure.” Exposure to airborne EtO without regard to the employee's use of respiratory protective equipment.

(1) Permissible Exposure Limit (PEL). The employer shall ensure that no employee is exposed to an 8-hour time-weighted average concentration of airborne EtO in excess of one (1) part EtO per million parts of air (1 ppm).

(2) Short Term Exposure Limit (STEL). The employer shall ensure that no employee is exposed to a concentration of airborne EtO in excess of 5 parts of EtO per million parts of air (5 ppm) as averaged over a sampling period of fifteen (15) minutes.

(d) Exposure Monitoring.

(1) General.

(A) Determinations of employee exposure shall be made from breathing zone air samples that are representative of the 8-hour time-weighted average exposure of each employee.

(B) Determinations of representative employee exposure shall be based on one or more samples representing full-shift exposure for each shift for each job classification in each work area.

(C) Where the employer can document that exposure levels are equivalent for similar operations on different work shifts, the employer need only determine representative employee exposure for such operations during one shift.

(2) Initial Monitoring.

(A) Each employer who has a workplace or work operation covered by this regulation, except as provided for in subsections (a)(2) or (d)(2)(B), shall perform initial monitoring to determine accurately the concentrations of airborne EtO to which employees may be exposed.

(B) Where the employer has monitored after June 15, 1983 and the monitoring satisfies all other requirements of this section, the employer may rely on such earlier monitoring results to satisfy the requirements of subsection (d)(2)(A).

(3) Monitoring Frequency (Periodic Monitoring).

(A) If the monitoring required by subsection (d)(2) reveals employee exposure at or above the action level but not above the permissible exposure limit, the employer shall repeat such monitoring for each such employee at least every 6 months.

(B) If the monitoring required by subsection (d)(2)(A) reveals employee exposure above the permissible exposure limit, the employer shall repeat such monitoring for each such employee at least every 3 months.

(C) The employer may alter the monitoring schedule from quarterly to semiannually for any employee for whom two consecutive measurements taken at listed 7 days apart indicate that the employee's exposure has decreased to or below the permissible exposure limit.

(D) If the monitoring required by subsection (d) (2) (A) reveals employee exposure above the STEL, the employer shall repeat such monitoring for each such employee at least every 3 months, and more often as necessary to evaluate the employee's short term exposures.

(4) Termination of Monitoring.

(A) If the initial monitoring required by subsection (d)(2)(A) reveals employee exposure to be below the action level, the employer may discontinue the monitoring for those employees whose exposures are represented by the initial monitoring.

(B) If the periodic monitoring required by subsection (d)(3) reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are below the action level, the employer may discontinue the monitoring for those employees whose exposures are represented by such monitoring.

(C) If the initial monitoring required by subsection (d) (2) reveals employee exposure to be at or below the STEL, the employer may discontinue short term exposure monitoring for those employees whose exposures are represented by the initial monitoring.

(D) If the periodic monitoring required by subsection (d) (3) (D) reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are at or below the STEL, the employer may discontinue short term exposure monitoring for those employees whose exposures are represented by such monitoring.

(5) Additional Monitoring. Notwithstanding the provisions of subsection (d)(4), the employer shall institute the exposure monitoring required under subsections (d)(2)(A) and (d)(3) whenever there has been a change in the production, process, control equipment, personnel or work practices that may result in new or additional employee exposures or when the employer has any reason to suspect that a change may result in new or additional exposures.

(6) Accuracy of Monitoring.

(A) Monitoring shall be accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for concentrations of airborne EtO at the permissible exposure limit and to within plus or minus 35 percent for concentrations of airborne EtO at the action level.

(B) Monitoring shall be accurate, to a confidence level of 95 percent, to within plus or minus 35 percent for concentrations of airborne EtO at the STEL.

(7) Employee Notification of Monitoring Results.

(A) The employer shall, within 15 working days after the receipt of the results of any monitoring performed under this regulation, notify the affected employee of these results in writing either individually or by posting the results in an appropriate location that is accessible to affected employees.

(B) The written notification required by subsection (d)(7)(A) shall describe the corrective action being taken by the employer to reduce employee exposure to or below the PEL or STEL wherever monitoring results indicated that the PEL and/or STEL has been exceeded.

(e) Regulated Areas.

(1) The employer shall establish a regulated area wherever employee exposures may exceed the PEL or can reasonably be expected to exceed the STEL.

(2) Access to regulated areas shall be limited to authorized persons.

(3) Regulated areas shall be demarcated in any manner that minimizes the number of employees within the regulated area.

(A) The employer shall institute engineering controls and work practices to reduce and maintain employee exposure to or below the PEL except to the extent that such controls are not feasible.

(B) Wherever the feasible engineering controls and work practices that can be instituted are not sufficient to reduce employee exposure to or below the PEL, the employer shall use them to reduce employee exposure to the lowest levels achievable by these controls and shall supplement them by the use of respiratory protection that complies with the requirements of subsection (g).

NOTE: Engineering controls are generally infeasible for the following operations: collection of quality assurance sampling from sterilized materials; removal of biological indicators from sterilized materials; loading and unloading of tank cars; changing of ethylene oxide tanks on sterilizers; and vessel cleaning. For these operations, engineering controls are required only where the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor or the Chief demonstrate that such controls are feasible.

(2) Compliance Program.

(A) Where the PEL is exceeded, the employer shall establish and implement a written program to reduce employee exposure to or below the PEL by means of engineering and work practice controls, as required by subsection (f)(1), and by the use of respiratory protection where required or permitted under this section.

(B) The compliance program shall include a schedule for periodic leak detection surveys and, as specified in subsection (h)(1), a written plan for emergency situations.

(C) Written plans for a program required in subsection (f)(2) shall be developed and furnished upon request for examination and copying to authorized representatives of the Chief, the Director, affected employees and designated employee representatives. Such plans shall be reviewed at least every 12 months, and shall be updated as necessary to reflect significant changes in the status of the employer's compliance program.

(D) The employer shall not implement a schedule of employee rotation as a means of compliance with the PEL or the STEL.

(g) Respiratory Protection and Personal Protective Equipment.

(1) General. For employees who are required to use respirators by this section, the employer must provide respirators that comply with the requirements of this subsection. Respirators must be used during:

(A) Periods necessary to install or implement feasible engineering and work practice controls;

(B) Work operations such as maintenance and repair activities, vessel cleaning, or other activities for which engineering and work practice controls are not feasible;

(C) Work operations for which feasible engineering and work practice controls are not yet sufficient to reduce exposure to or below the PEL; and

(D) Emergencies.

(2) Respirator program. The employer must implement a respiratory protection program in accordance with section 5144(b) (except (d)(1)(C)) through (m).

(3) Respirator Selection.

(A) The employer shall select, and provide to employees, the appropriate respirators specified in Section 5144(d)(3)(A)1; however, employers shall not select or use half masks of any type because EtO may cause eye irritation or injury.

(B) Each air-purifying, full facepiece respirator shall be equipped with a front- or back-mounted canister approved for protection against ethylene oxide.

(C) For escape, the employer shall provide employees with any respirator permitted for use under subsections (g)(3)(A) and (B).

(4) Protective Clothing and Equipment. Where eye or skin contact with liquid EtO or EtO solutions may occur, the employer shall select and provide, at no cost to the employee, appropriate protective clothing or other equipment in accordance with Sections 3380, 3382, 3383, and 3384 to protect any area of the body that may come in contact with liquid EtO or EtO in solution and shall ensure that the employee wears the protective clothing and equipment provided.

(h) Emergency Situations.

(1) Written Plan.

(A) A written plan for emergency situations shall be developed for each workplace where there is a possibility of an emergency. Appropriate portions of the plan shall be implemented in the event of an emergency.

(B) The plan shall specifically provide that employees engaged in correcting emergency conditions shall be equipped with respiratory protection as required by subsection (g) until the emergency is abated.

(2) Alerting Employees. Where there is the possibility of employee exposure to EtO due to an emergency, means shall be developed and provided to promptly alert potentially affected employees upon such occurrences. Affected employees not engaged in correcting the emergency conditions shall be immediately evacuated from the area and shall not be permitted to return until the emergency is abated.

(3) Reporting of Emergencies. Emergencies shall be reported to the Chief in accordance with subsection (m).

(i) Medical Surveillance.

(1) General.

(A) The employer shall institute a medical surveillance program for all employees who are or may be exposed to EtO at or above the action level, without regard to the use of respirators, for at least 30 days a year.

(B) The employer shall make available medical examinations and consultations to all employees who have been exposed to EtO in an emergency situation.

(C) The employer shall ensure that all medical examinations and procedures are performed by or under the supervision of a licensed physician and are provided without cost to the employee, without employee loss of pay, and at a reasonable time and place.

(2) Frequency of Medical Examinations and Consultations. The employer shall make medical examinations and consultations available to each employee covered under subsections (i)(1)(A) and (B) on the following schedules:

(A) Prior to assignment of the employee to an area where exposure may be at or above the action level for at least 30 days a year.

(B) At least annually for each employee exposed at or above the action level for at least 30 days in the preceding year.

(C) At termination of employment or upon reassignment to an area where employee exposure is not at or above the action level for at least 30 days a year.

(D) As medically appropriate for any employee exposed during an emergency.

(E) As soon as possible following notification of the employer by an employee either (1) that the employee has developed signs or symptoms indicating possible overexposure to EtO, or (2) that the employee desires medical advice concerning the effects of current or past exposure to EtO on the employee's ability to produce a healthy child.

(F) If the examining physician determines that any of the examinations should be provided more frequently than specified, the employer shall provide such examination to affected employees at the frequencies recommended by the physician.

1. A medical and work history with special emphasis directed to symptoms related to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin;

2. A physical examination with particular emphasis given to the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin;

3. A complete blood count to include at least a white cell count (including differential cell count) and red cell count and hematocrit and hemoglobin determinations; and

4. Any laboratory or other test which the examining physician deems necessary by sound medical practice.

(B) The content of medical examinations or consultations made available pursuant to subsection (i)(2)(E) shall be determined by the examining physician and shall include pregnancy testing or laboratory evaluation of fertility if requested by the employee and deemed appropriate by the physician.

(4) Information Provided to the Physician. The employer shall provide the following information to the examining physician:

(A) A copy of this standard and Appendices A, B and C;

(B) A description of the affected employee's duties as they relate to the employee's exposure;

(D) A description of any personal protective and respiratory equipment used or to be used; and

(E) Information from previous medical examinations of the affected employee that is not otherwise available to the examining physician.

(5) Physician's Written Opinion.

(A) The employer shall obtain a written opinion from the examining physician. This written opinion shall contain the results of the medical examination and shall include:

1. The physician's opinion as to whether the employee has any detected medical conditions that would place the employee at an increased risk of material health impairment from exposure to EtO;

2. Any recommended limitations on the employee or upon the use of personal protective equipment such as clothing or respirators; and

3. A statement that the employee has been informed by the physician of the results of the medical examination and of any medical conditions resulting from EtO exposure that require further explanation or treatment.

(B) The employer shall instruct the physician not to reveal in the written opinion given to the employer specific findings or diagnoses unrelated to occupational exposure to EtO.

(C) The employer shall provide a copy of the physician's written opinion to the affected employee within 15 days from its receipt.

(B) In classifying the hazards of EtO at least the following hazards are to be addressed: Cancer; reproductive effects; mutagenicity; central nervous system; skin sensitization; skin, eye and respiratory tract irritation; acute toxicity effects; and flammability.

(C) Employers shall include EtO in the hazard communication program established to comply with the HCS (Section 5194). Employers shall ensure that each employee has access to labels on containers of EtO and to safety data sheets, and is trained in accordance with the requirements of HCS and subsection (j)(3) of this section.

(2) Signs and Labels.

(A) Signs.

1. The employer shall post and maintain legible signs demarcating regulated areas and entrances or access ways to regulated areas that bear the following legend:

DANGER

ETHYLENE OXIDE

MAY CAUSE CANCER

MAY DAMAGE FERTILITY OR THE UNBORN CHILD

RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS AREA

AUTHORIZED PERSONNEL ONLY

2. Prior to June 1, 2016, employers may use the following legend in lieu of that specified in subsection (j)(2)(A)1. of this section:

DANGER

ETHYLENE OXIDE

CANCER HAZARD AND REPRODUCTIVE HAZARD

AUTHORIZED PERSONNEL ONLY

RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS AREA

(B) Labels.

1. The employer shall ensure that precautionary labels are affixed to all containers the contents of which are capable of causing employee exposure at or above the action level, or the contents of which may reasonably be foreseen to cause employee exposure above the excursion limit and that the labels remain affixed when the containers leave the workplace. For the purposes of this subsection (j)(2)(B), reaction vessels, storage tanks and pipes or piping systems are not considered to be containers.

2. Prior to June 1, 2015, employers may include the following information on containers of EtO in lieu of the labeling requirements in subsection (j)(1)(A) of this section:

a. DANGER

CONTAINS ETHYLENE OXIDE

CANCER HAZARD AND REPRODUCTIVE HAZARD;

b. A warning statement against breathing airborne concentrations of EtO.

(C) The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C.136 et seq.), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency.

(3) Information and Training.

(A) The employer shall provide employees who are potentially exposed to EtO at or above the action level with information and training on EtO at the time of initial assignment and at least annually thereafter.

(B) Employees shall be informed of the following:

1. The requirements of this regulation with an explanation of its contents, including Appendices A and B;

2. All operations in their work area where EtO is present;

3. The location and availability of this regulation within the workplace; and

4. The medical surveillance program required by subsection (i) with an explanation of the information in Appendix C.

(C) Employee training shall include at least:

1. Methods and observations that may be used to detect the presence or release of EtO in the work area (such as monitoring conducted by the employer, continuous monitoring devices, etc.);

2. The physical and health hazards of EtO;

3. The measures employees can take to protect themselves from hazards associated with EtO exposure, including specific procedures the employer has implemented to protect employees from exposure to EtO, such as work practices, emergency procedures, and personal protective equipment to be used; and

4. The details of the hazard communication program developed by the employer in accordance with Section 5194, including an explanation of the labeling system and how employees can obtain and use the appropriate hazard information.

(k) Recordkeeping.

(1) Objective Data For Exempted Operations.

(A) Where the processing, use, or handling of products made from or containing EtO are exempted from other requirements of this regulation under subsection (a)(2), or where objective data such as earlier monitoring have been relied on in lieu of initial monitoring under subsection (d)(2)(B), the employer shall establish and maintain an accurate record of objective data reasonably relied upon in support of the exemption.

(B) This record shall include at least the following information:

1. The product qualifying for exemption;

2. The source of the objective data;

3. The testing protocol, results of testing, and/or analysis of the material for the release of EtO;

4. A description of the operation exempted and how the data support the exemption; and

5. Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.

(C) The employer shall maintain this record for the duration of the employer's reliance upon such objective data.

(2) Exposure Measurements.

(A) The employer shall keep an accurate record of all measurements taken to monitor employee exposure to EtO as prescribed in subsection (d).

(B) This record shall include at least the following information:

1. The date of measurement;

2. The operation involving exposure to EtO which is being monitored;

3. Sampling and analytical methods used and evidence of their accuracy;

4. Number, duration, and results of samples taken;

5. Type of protective devices worn, if any; and

6. Name, social security number and exposure of the employees whose exposures are represented.

(C) The employer shall maintain this record for at least thirty (30) years.

(3) Medical Surveillance.

(A) The employer shall establish and maintain an accurate record for each employee subject to medical surveillance as prescribed by subsection (i)(1).

(B) The record shall include at least the following information:

1. The name and social security number of the employee;

2. Physicians' written opinions;

3. Any employee medical complaints related to exposure to EtO; and

4. A copy of the information provided to the physician as required by subsection (i)(4).

(C) The employer shall ensure that this record is maintained for the duration of employment plus thirty (30) years.

(4) Availability.

(A) The employer, upon written request, shall make all records required to be maintained by this section available to authorized representatives of the Chief and the Director for examination and copying.

(B) The employer, upon request, shall make any exemption and exposure records required by subsections (k)(1) and (k)(2) of this section available for examination and copying to affected employees, former employees, designated representatives, and authorized representatives of the Chief, in accordance with Section 3204(a)-(e) and (g)-(i).

(C) The employer, upon request, shall make employee medical records required by subsection (k)(3) available for examination and copying to the subject employee, anyone having the specific written consent of the subject employee, and authorized representatives of the Chief, in accordance with Section 3204.

(5) Transfer of Records.

(A) The employer shall comply with the requirements concerning transfer of records set forth in Section 3204(h).

(B) Whenever the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director in writing at least 90 days prior to their disposal and shall transmit them to the Director if requested to do so within the 90-day period.

(l) Observation of Monitoring.

(1) Employee Observation. The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to EtO conducted in accordance with subsection (d).

(2) Observation Procedures. When observation of the monitoring of employee exposure to EtO requires entry into an area where the use of protective clothing or equipment is required, the observer shall be provided with and be required to use such clothing and equipment and shall be required to comply with all of the applicable safety and health procedures.

(m) Notification of Use and Emergencies. See section 5203.

(n) Appendices. The information contained in the appendices is not intended by itself to create any additional obligations nor otherwise imposed by this section or to detract from any existing obligation.